CLB
Lyon, France
Location contact
Amandine BERTRAND, MD
CONTACT
Amandine BERTRAND, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07515274
This is a category 2 human research study (RIPH), interventional, single-center, prospective, open-label.
The primary objective of this study is to qualitatively assess the effects of equicoaching on social reintegration in young adults who have been treated for cancer.
The secondary objectives are to evaluate the contribution of equicoaching to:
1. Self-confidence; 2. Well-being 3. Quality of life Satisfaction with equicoaching will also be evaluated.
Trial opening soon.
Get Notified15 year–25 year
All sexes
Interventional
Not applicable
Lyon, France
Amandine BERTRAND, MD
CONTACT
Amandine BERTRAND, MD
PRINCIPAL_INVESTIGATOR
The study will be systematically offered via DAJAC referral nurses and/or the referral oncohematologist to all IHOPe patients (and their parent/legal guardian in the case of minors), in accordance with the inclusion and exclusion criteria, during follow-up consultations or during the multidisciplinary end-of-treatment day. The study team will keep a list of eligible patients to ensure the completeness of possible inclusions and the study acceptance rate. The information sheet and consent form will be provided, a reasonable reflection period will be allowed, and the investigator will answer any questions if necessary. If the patient agrees to participate, they will give their written consent by personally dating and signing the consent form (or parents will sign for minor patients). After collecting the study-specific consent form, an initial meeting will be held at the CLB between the participants and members of the project team. The purpose of this meeting is to get to know each other and create group dynamics. This initial discussion will also provide an opportunity to explain the overall objectives and outline the intervention with the participants.
An initial individual interview will be organized with each participant involved in order to discuss their experience of the disease, their social relationships, their leisure activities, their relationship with horses, and their relationship with sport, exploring their experiences and practices in physical activities. Questionnaires to assess quality of life, well-being, and self-confidence will be completed during this interview. This will be followed by equicoaching. This intervention will be carried out by two qualified professionals over a period of six months and will consist of six monthly group sessions at an equestrian center in Ste Consorce (69), combined with monthly individual follow-up via videoconference.
The various group sessions will address the following topics:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
For minors:
Exclusion criteria
An initial individual interview will be organized with each participant to discuss their experience of the disease, their social relationships, their leisure activities, their relationship with horses, and their relationship with sports, exploring their experiences and practices in physical activities. Questionnaires to assess quality of life, well-being, and self-confidence will be completed during this interview.
This will be followed by equicoaching. This intervention will be carried out by two qualified professionals over a period of six months and will consist of six monthly group sessions combined with individual follow-up. This will be followed by equicoaching. This intervention will be carried out by two qualified professionals over a period of six months and will consist of six monthly group sessions combined with monthly individual follow-up via videoconference. The various group sessions will address different topics.
After each group session, the AJAs will have individual i
Time frame: Inclusion and month 6
Social reintegration will be assessed using a qualitative comparative analysis of two individual semi-structured interviews conducted at baseline and six months after the intervention.
Interview topics will include illness trajectory, social and family relationships, level of autonomy and independence, ability to plan for the future, social participation, and participants' perceptions of the equicoaching intervention.
All interviews will be audio-recorded, transcribed verbatim, and analyzed using thematic analysis with NVivo software to identify changes in themes and subthemes over time.
Time frame: Inclusion and month 6
Self-esteem will be measured using the Rosenberg Self-Esteem Scale, a 10-item self-administered questionnaire.Total scores range from 10 to 40, with higher scores indicating better self-esteem.
Time frame: Inclusion and month 6
Mental well-being will be assessed using the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS), a 14-item self-administered questionnaire measuring positive aspects of mental health.Total scores range from 14 to 70, with higher scores indicating better mental well-being.
Time frame: Inclusion and month 6
Emotional functioning will be measured using the Emotional Functioning subscale of the Pediatric Quality of Life Inventory (PedsQL).The subscale consists of 5 items assessing emotional difficulties. Items are scored on a 5-point Likert scale and transformed to a 0-100 scale, with higher scores indicating better emotional functioning.
Centre Leon Berard
Other
Acronym: EQUICAP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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